A Study of Denosumab in Multiple Myeloma Patients With Renal Insufficiency (NCT02833610) | Clinical Trial Compass
CompletedPhase 2
A Study of Denosumab in Multiple Myeloma Patients With Renal Insufficiency
United States55 participantsStarted 2016-08
Plain-language summary
This research study is studying a possible therapy as a possible treatment for the consequences of Multiple Myeloma with renal insufficiency.
Who can participate
Age range18 Years
SexALL
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Inclusion Criteria:
* Patients with symptomatic MM as defined by IMWG requiring anti-myeloma therapy.
* Monoclonal plasma cells in the bone marrow greater than or equal to 10% and/or presence of a biopsy-proven plasmacytoma
* Monoclonal protein present in the serum and/or urine
* Creatinine clearance \< 30 mL/min, not eligible for bisphosphonate. Estimated glomerular filtration rate will be calculated using Cockcroft-Gault equation.
* Serum calcium or albumin-adjusted serum calcium ≥ 2.1 mmol/L (8.4 mg/dL) and ≤ 2.9 mmol/L (11.5 mg/dL) (Reference range 8.5-10.8 mg/dL)
* Able to tolerate daily supplementation of calcium and vitamin D
* Vitamin D level ≥ 30 ng/mL after repletion
* Participants must have normal organ as defined below:
* Total bilirubin ≤ 2.0 x ULN
* AST(SGOT) ≤2.5 × institutional upper limit of normal
* ALT(SGPT) ≤2.5 × institutional upper limit of normal
* Plan to receive anti-myeloma therapies.
* Age ≥ 18 years.
* ECOG performance status ≤ 2
* Life expectancy greater than 6 months
* 0-3 lines of prior anti-myeloma therapy.
* Subjects with reproductive potential must be willing to use, in combination with his/her partner, 2 highly effective methods of effective contraception or practice sexual abstinence throughout the study and continue for 5 months after the study duration. Subjects who are surgically sterile (e.g. history of bilateral tubal ligation, hysterectomy) or whose sexual partner is sterile (e.g. history of vasectomy) are not required to…